Pilot Study of Negative Pressure Neck Therapy (NPNT)

N/ANot Yet RecruitingNCT07301567

University of British Columbia10 enrolled

Overview

Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants will undergo 2 separate home sleep apnea tests (HSAT) approximately 1 week apart and will be randomly assigned to wear the NPNT device at either night 1 or night 2 of HSAT. Participation will include 5 on-site visits and 1 phone call over approximately 1 month.

Purpose: To determine the safety and efficacy of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants. Negative pressure neck therapy (NPNT) uses a self-contained, non-invasive, external device to apply a gentle, outward pulling effect around the neck's surface. Hypothesis: Given the exploratory nature and small sample size no formal hypothesis testing will be conducted Objectives: Primary Objective: 1\. To determine if NPNT can effectively reduce the number of apnea-hypopnea index (AHI) events (sleep disorder breathing events) in healthy participants. Secondary Objectives: 1. To determine the tolerability of the NPNT 2. To determine the duration of time required for acclimating to the device 3. To determine the NPNT parameters (optimal device fit) based on participant characteristics. 4. To collect feedback from participants regarding the device use, comfort, fit, function, usability, etc. Safety and Efficacy Objectives: 1. To evaluate the safety and effectiveness of NPNT 2. To assess potential side effects of NPNT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index ≤42 kg/m2 * Able to speak, read, and write English Exclusion Criteria: * Known sleep disorder such as Obstructive Sleep Apnea (OSA), narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia * No previous surgery, injury, or radiation to the neck * Excessive hair or beard in the area of the neck, and/or unwillingness to shave that area for the duration of this study * Inflammatory skin condition, such as acne or eczema in the neck area * Known silicone allergy * Night shift work because of irregular sleep-wake cycles * Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks * Use of illicit drugs currently or within the past 5 years * Serious pulmonary disease * Use of home oxygen or oxygen saturation \<94% * Cancer that has been in remission for less than one year * Previous surgery for peripheral arterial disease

Outcomes

Primary Outcomes

Comparison of the number of sleep-disordered breathing events between intervention and control nights as assessed by Home Sleep Apnea Test (HSAT).

Change between control night and intervention night on mean AHI (Apnea-Hypopnea Index) scores. A positive treatment effect will be attributed to the NPNT device if the difference between the mean AHI score on intervention night is less than the mean AHI score on control night. A score of less than 0 is positive. Measurement Tool: HSAT (Home Sleep Apnea Test) Unit of Measure: AHI (Apnea-Hypopnea Index) scores

Time frame: 1 night

Secondary Outcomes

Tolerability of NPNT device based on duration of time (hours) worn during NPNT intervention night as assessed by Participant Report and Home Sleep Apnea Test (HSAT)

Wear time (hours) of NPNT device will be assessed for each participant during the NPNT intervention night, after 7 day NPNT acclimatization period. Mean, median, range of tolerability of scores will be reported. Measurement Tool: Participant Reported and HSAT (Home Sleep Apnea Test) Unit of Measure: hours

Time frame: 1 night

Participant Characteristics will be assessed compared to NPNT device fit/shape based on participant response on the Device Evaluation Questionnaire using Likert scores.

Descriptive participant traits (age, BMI, craniofacial markers, etc.) will plotted against NPNT device fit/shape Likert scores from the Device Evaluation Questionnaire above and below a score of 3. For example, fit/shape Likert score rating by BMI category. Measurement Tool: Device Evaluation Questionnaire and Participant demographics Unit of Measure: Likert Score

Time frame: 1 night

Participant reported device tolerability will be assessed using the Device Evaluation Questionnaire Likert scale responses.

Proportion of participants rating NPNT device as "tolerable" (≥3 on Likert scale) during NPNT intervention night, after 7 day acclimatization period. Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Likert scale

Time frame: 1 night

Participant Reported Feedback on shape and fit of NPNT device as assessed by the Device Evaluation Questionnaire using a Likert Scale (≥3 on Likert scale)

Proportion of participants rating device as "Moderate/good/excellent" (e.g., ≥3 on Likert scale). Mean, median, range of shape/fit scores, including a breakdown by demographic/ BMI group will be assessed after NPNT intervention night and 7 day acclimatation period. Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Likert scale

Time frame: 1 night

Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale

Proportion of participants rating device comfort, usability and function as ≥3 on Likert scale. Mean, median, range of device comfort, usability and function scores, including a breakdown by demographic/ BMI group will be assessed after NPNT intervention night and after 7 day acclimatation period. Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Likert scale

Time frame: 1 night

Participant Feedback on NPNT device based on qualitative data (open comments) from the Device Evaluation Questionnaire after the NPNT device intervention night.

Qualitative data will be summarized using simple thematic coding based on participant open comment section of the Device Evaluation Questionnaire after the NPNT device intervention night, after 7 day acclimatization period. Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Qualitative data (open comments)

Time frame: 1 night

Pilot Study of Negative Pressure Neck Therapy (NPNT)

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts